- Eisai, Inc (Exton, PA)
- …CTAs) and agency communications (responses to questions) are prepared in compliance with the applicable regulatory requirements and scientific ... Job Summary Implements global chemistry, manufacturing and control (CMC) regulatory strategies throughout the lifecycle of pharmaceuticals. Coordinates the… more
- Aequor (Austin, TX)
- …and procedures, providing support and corrective actions where required Assists overall Project Manager with all matters related to strategic sourcing and ... teams Be the Procurement Process and Systems expert ensuring compliance with all relevant global sourcing policies and procedures,...Project Delivery teams and suppliers Develop and maintain Project Sourcing Plan with Project Manager… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: Manager , Sales Training and Development - Oncology serves as the training subject ... and ensure all projects and materials have been through the correct regulatory review process before being delivered to field sales forces.Support secondary customer… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …new vendors and oversee infrastructure projects to ensure robust and secure IT environments. Regulatory Compliance : Ensure IT systems comply with 21 CFR Part 11, ... Pharma Sciences is seeking an experienced and dynamic Senior Manager , IS Quality to build and lead our IS...audit programs and lead IS quality audits to ensure regulatory compliance and successful outcomes. Participate in… more
- Merck & Co. (Durham, NC)
- …participate on cross-functional teams in an inclusive manner to advance project goals and achieve deliverables.Hire, develop, motivate, and manage a team ... Controllers (PLC), robotics)Maintenance Equipment (eg tools and calibration equipment) Compliance : Ensure that maintenance activities are executed in compliance… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …the Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance , will oversee end-to-end contract ... of the Office of Research Contracts (ORC).The Contracts Manager - Federal Contracts and Compliance will...DCA audits and prepare and file all necessary governmental regulatory reports and plans.The Manager will also… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. The Sr. Product Manager (SPM), US Oncology Women's Cancer, is responsible for contributing to the strategic ... communications and strategies across the brand's target audiences and to ensure regulatory /legal requirements are met. The SPM will lead efforts on developing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …brand marketing, market access, commercial effectiveness, sales, medical/CMR, legal, compliance , and regulatory . Other internal relationships include Public ... Brand Marketing, Training, Commercial Insights and Analytics, Managed Markets, Legal, Compliance , and Finance. The position has high exposure to senior management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of post-law school experience required- 4 or More Years experience in regulatory , compliance , and legal matters relating to investigational products, product ... but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Aequor (Thousand Oaks, CA)
- …taking into account the MSP fee) As part of Global Labeling Strategy and Compliance (LSC), and under the supervision of the Therapeutic Area Lead, the Labeling ... Manager is responsible for supporting the facilitation and management...the labeling documents review/governance Represents labeling on product-specific global regulatory teams Leads the development and maintenance of core… more
- Novo Nordisk Inc. (WA)
- …research (patient safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance ) for monitoring and site management ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and approval workflows within the DAM system to maintain content integrity and compliance with regulatory requirements. Stay informed about emerging trends and ... actionable marketing strategies to guide customer experiences Strong understanding of regulatory , compliance , and ethical considerations in engaging with… more
- Novo Nordisk Inc. (Durham, NC)
- …tools within the main areas of Systematic Problem Solving, process improvement, & project management Operate within compliance with a Quality Mindset that ... process control systems to meet current & projected customer, business & regulatory requirements through the following activities: People Focus, Equipment Focus &… more
- American Honda Motor Co Inc (Marysville, OH)
- …as developing a new test, designing systems, traveling to suppliers or serving as a project manager ! In addition to the full-time associate work that our Co-ops/ ... in the following areas, projects may include:Manufacturing (Plant Safety): Safety compliance (OSHA, NFPA, ANSI regulatory requirements) confined space… more
- Aequor (Pearl River, LA)
- …editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with regulatory requirements. Must be able to work quickly ... and completeness of documentation 3. Provide summary reports to management and project team on the status of documentation activities 4. Ensure compliance… more
- Merck & Co. (Durham, NC)
- …calibration, and maintenance support for a new product feasibility project /manufacturing support. Develops standard operating procedures (SOP's) and preventative ... guided by policies, procedures and business plan; receives guidance from manager Manage multiple priorities and advance several tasks in parallel, troubleshooting… more
- Merck & Co. (Durham, NC)
- …troubleshooting and maintenance support for a new product feasibility project /manufacturing support. Develops standard operating procedures (SOP's) and preventative ... guided by policies, procedures and business plan; receives guidance from manager .Manage multiple priorities and advance several tasks in parallel.Must be flexible… more
- ConsultNet (Salt Lake City, UT)
- Senior IT Project Manager Salt Lake City, UT Long-Term Contract: $60-$80 per hour An experienced Senior IT Project Manager is needed to lead the ... enhancing data processing capabilities and supporting future scalability. The Project Manager will lead one or more...are completed within the target release date. * Ensure compliance with technical, security, and regulatory standards… more
